Akeso's Ivonescimab (PD-1/VEGF BsAbs) Granted Breakthrough Therapy Designation by China NMPA for the Treatment of Advanced NSCLC

HONG KONG,Oct. 21,2022 -- Akeso,Inc. (9926. HK) ("Akeso"),a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology,announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy for treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR-mutated who failed to prior EGFR-TKI treatment.

It is Ivonescimab's second breakthrough therapy designation for lung cancer treatment,and NMPA granted the first one in September 2022 for the first-line treatment of NSCLC patients with positive PD-L1 expression.

Breakthrough Therapy Designation procedure in China is designed to expedite the development and review of innovative drugs with apparent clinical benefits. Chinese regulators will prioritize resources for communication,enhance guidance and facilitate drug development for those drugs included in the procedure of BTD. Drug candidates with BTD can be considered for conditional approval and priority review when submitting a New Drug Application (NDA).

Currently,two Phase III trials of Ivonescimab for major lung cancer indications are ongoing. Receiving the Breakthrough Therapy Designation will accelerate the clinical development and product launch process of Ivonescimab,also further demonstrating the clinical value-oriented drug development concept and innovation capability of Akeso.

About Ivonescimab(PD-1/VEGF,Ak112)

Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso. Engineered with the company's unique Tetrabody technology,Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2,and blocks VEGF binding to VEGF receptors. PD-1 antibodies combined with VEGF-blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma,non-small cell lung cancer,and hepatocellular carcinoma). Given the co-expression of VEGF and PD-1 in the tumor microenvironment,Ivonescimab,as a single agent to block these two targets,may block these two pathways more effectively and enhance the antitumor activity,as compared to combination therapy.

Currently,Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition,a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages of treatment of indications,including non-small cell lung cancer and small cell lung cancer.

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